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You are about to leave bmsstudyconnect.com. The site you are linking to is not controlled or endorsed by Bristol Myers Squibb and Bristol Myers Squibb is not responsible for the content provided on that site.
You are about to leave bmsstudyconnect.com. The site you are linking to is not controlled or endorsed by Bristol Myers Squibb and Bristol Myers Squibb is not responsible for the content provided on that site.
You are about to leave bmsstudyconnect.com. The site you are linking to is not controlled or endorsed by Bristol Myers Squibb and Bristol Myers Squibb is not responsible for the content provided on that site.
You are about to leave bmsstudyconnect.com. The site you are linking to is not controlled or endorsed by Bristol Myers Squibb and Bristol Myers Squibb is not responsible for the content provided on that site.
You are about to leave bmsstudyconnect.com. The site you are linking to is not controlled or endorsed by Bristol Myers Squibb and Bristol Myers Squibb is not responsible for the content provided on that site.
This link takes you to a website of Bristol Myers Squibb that may have a different purpose, may have different terms and conditions, and is being provided solely to enable you to contact Bristol Myers Squibb.
You are about to leave bmsstudyconnect.com. The site you are linking to is not controlled or endorsed by Bristol Myers Squibb and Bristol Myers Squibb is not responsible for the content provided on that site.
This link takes you to a website of Bristol Myers Squibb that may have a different purpose, may have different terms and conditions, and is being provided solely to enable you to contact Bristol Myers Squibb.
This link takes you to a website of Bristol Myers Squibb that may have a different purpose, may have different terms and conditions, and is being provided solely to enable you to contact Bristol Myers Squibb.
This link takes you to a website of Bristol Myers Squibb that may have a different purpose, may have different terms and conditions, and is being provided solely to enable you to contact Bristol Myers Squibb.
Active, Not Recruiting
A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS) - CA055-026
Updated:
27 August, 2024
|
ClinicalTrials.gov
Phase
Gender(s)
Age Range
Active, Not Recruiting
Inclusion Criteria: • Participant has a documented diagnosis of MDS according to WHO 2016 classification that meets International Prognostic Scoring System Revised (IPSS-R) classification of low- or intermediate-risk disease (IPSS-R score between 1.5 and 4.5). MDS diagnosis, WHO classification, and IPSS-R risk classification will be prospectively determined by independent central pathology and cytogenetics review, and applicable central laboratory results. • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Exclusion Criteria: - Participants with prior malignancies must have an expected median life expectancy of at least 12 months at the time of inclusion and no active treatment of any sort for at least 24 weeks prior to randomization (including but not limited to immunotherapy or targeted therapy) - Hypoplastic Myelodysplastic Syndrome (MDS) with a marrow cellularity of ≤ 10% - Participants diagnosed with MDS with excess blasts-2 (MDS-EB2) - Prior treatment with azacitidine (any formulation), decitabine, or other hypomethylating agent Other protocol-defined inclusion/exclusion criteria apply
We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information
466-SE-2100058